Prostate Cancer
EA8191 / INDICATE
Treating Prostate Cancer That Has Come Back after Surgery with Apalutamide and Targeted Radiation Based on PET Imaging, INDICATE Trial
STATUS: Active
This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer).
A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.
Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
- STEP 0: REGISTRATION ELIGIBILITY CRITERIA
- Patient must be male and >= 18 years of age
- Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
- Patient must have biochemical recurrence (BCR) after RP, meeting one of the criteria below: * PSA level of >0.2 ng/mL at any time after RP if patient had first detectable PSA within 12 months after RP. First detectable = first non-zero value reported, any value higher than the lower limit of normal for that assay (Note: Patients with a persistent post-RP PSA reading of >0.2 ng/mL are automatically eligible). OR * PSA level of >0.5 ng/mL at any time after RP if patient had first detectable PSA more than 12 months after RP. First detectable = first non-zero value reported, any value higher than the lower limit of normal for that assay. OR * NO minimum PSA requirement if the patient has a detectable PSA (any value higher than the lower limit of normal for that assay) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any body location
- Patients must have no definite evidence for extrapelvic metastatic disease. This may be determined by CIM (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy or equivalent) within 26 weeks prior to step 0 registration. If patient does not have prior CIM, an existing study-eligible = PET using FDA-approved radiotracer may be used to determine whether patient requires CIM. For patients who have study-eligible PET done without prior CIM: * Baseline CIM is required if the study-eligible PET is positive for extrapelvic lesions. Patient should have a baseline CT/MRI (e.g. for soft tissue lesions) and performed within 16 weeks prior to study registration./or a bone scan (e.g. for osseous lesions), for further evaluation of the PET-detected extrapelvic lesion(s). * Baseline CIM is not required if the study-eligible PET is negative for extrapelvic lesions. NOTE: Extra-pelvic metastases are defined as extrapelvic soft tissue, lymph node and organ metastases, and/or any osseous metastases; extra-pelvic is defined as superior to common iliac bifurcation, and/or outside of standard fields for prostate bed + whole pelvis nodal RT fields
- Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient must not have started short term ADT for biochemical recurrence prior to baseline PET (PET1), but may start short term ADT after PET and up to 7 days prior to study registration. * NOTE: A short course (e.g., ~ 4 weeks) of low-dose anti-androgen (e.g. bicalutamide), started given after PET1, either before or after study registration, is also permitted as a brief temporizing measure/bridge to protocol-approved SOC short term ADT
- Patient must not be actively receiving treatment in another therapeutic clinical trial
- Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
- Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI
- Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration
- Patient must not have history of inflammatory bowel disease or gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy to an unacceptable level, per institutional standard
- Hemoglobin (Hgb) >= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
- Leukocytes >= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
- Absolute neutrophil count >= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
- Platelets >= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
- Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, must have a direct bilirubin of < 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)
- Creatinine < 1.5 x institutional ULN (or measured creatinine clearance > 30 mL/min) (obtained within 8 weeks prior to Step 0 registration)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
- Patient must not have completed a course of prior pelvic external beam radiation therapy that would overlap with SOC RT fields used in this protocol, such that normal tissue constraints cannot be met
- Patient must agree not to father children while on study
- Patient must be English or Spanish speaking to be eligible for the QOL component of the study * NOTE: Sites cannot translate the associated QOL forms
- STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
- Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using an FDA approved radiotracer to establish presence or absence of extra-pelvic metastases on PET (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration
- For patients with PET scan results that are negative for extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
- For patients with PET scan results that are positive for extra-pelvic metastases [defined as any PET positive lesions outside of standard salvage RT fields (prostate bed +/- typical whole pelvis)], the number of extra-pelvic lesions must be known (1 - 5 or > 5 extra-pelvic lesions)
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Tampa
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Boise
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Kootenai Health - Coeur d'Alene
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Saint Luke's Cancer Institute - Twin Falls
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Alton
Alton Memorial Hospital
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Aurora
Rush - Copley Medical Center
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Memorial Hospital of Carbondale
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SIH Cancer Institute
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Illinois CancerCare-Carthage
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Centralia
Centralia Oncology Clinic
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Chicago
Northwestern University
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Danville
Carle at The Riverfront
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DeKalb
Northwestern Medicine Cancer Center Kishwaukee
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Decatur
Cancer Care Specialists of Illinois - Decatur
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Dixon
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Effingham
Carle Physician Group-Effingham
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Crossroads Cancer Center
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Eureka
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Galesburg
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Geneva
Northwestern Medicine Cancer Center Delnor
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Macomb
Illinois CancerCare-Macomb
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Mattoon
Carle Physician Group-Mattoon/Charleston
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Maywood
Loyola University Medical Center
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Mount Vernon
Good Samaritan Regional Health Center
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Cancer Care Center of O'Fallon
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Illinois CancerCare-Ottawa Clinic
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Valley Radiation Oncology
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Illinois CancerCare-Princeton
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UW Health Carbone Cancer Center Rockford
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Memorial Medical Center
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Carle Cancer Center
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Warrenville
Northwestern Medicine Cancer Center Warrenville
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Illinois CancerCare - Washington
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Garden City
Central Care Cancer Center - Garden City
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Central Care Cancer Center - Great Bend
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Lexington
Saint Joseph Hospital
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Louisville
Jewish Hospital
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MD
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
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Suburban Hospital
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Bath
MaineHealth Coastal Cancer Treatment Center
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MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
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MaineHealth Cancer Care Center of York County
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Maine Medical Center- Scarborough Campus
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Maine Medical Partners - South Portland
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MN
Burnsville
Minnesota Oncology - Burnsville
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Coon Rapids
Mercy Hospital
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Fairview Southdale Hospital
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Unity Hospital
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Fairview Clinics and Surgery Center Maple Grove
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Minnesota Oncology Hematology PA-Maplewood
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Saint John's Hospital - Healtheast
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Minneapolis
Abbott-Northwestern Hospital
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Health Partners Inc
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Monticello Cancer Center
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North Memorial Medical Health Center
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Coborn Cancer Center at Saint Cloud Hospital
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Park Nicollet Clinic - Saint Louis Park
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Regions Hospital
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Rice Memorial Hospital
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MO
Bolivar
Central Care Cancer Center - Bolivar
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Cape Girardeau
Saint Francis Medical Center
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Southeast Cancer Center
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Creve Coeur
Siteman Cancer Center at West County Hospital
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Farmington
Parkland Health Center - Farmington
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Jefferson City
MU Health Care Goldschmidt Cancer Center
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Freeman Health System
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Rolla
Delbert Day Cancer Institute at PCRMC
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Saint Joseph
Heartland Regional Medical Center
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Mercy Hospital Saint Louis
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Siteman Cancer Center at Saint Peters Hospital
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Sainte Genevieve County Memorial Hospital
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Springfield
CoxHealth South Hospital
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Mercy Hospital Springfield
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Sullivan
Missouri Baptist Sullivan Hospital
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Sunset Hills
BJC Outpatient Center at Sunset Hills
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MS
Grenada
Baptist Cancer Center-Grenada
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Jackson
University of Mississippi Medical Center
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New Albany
Baptist Memorial Hospital and Cancer Center-Union County
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Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
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MT
Billings
Billings Clinic Cancer Center
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Bozeman
Bozeman Health Deaconess Hospital
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Great Falls
Benefis Sletten Cancer Institute
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Great Falls Clinic
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Kalispell
Kalispell Regional Medical Center
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Missoula
Community Medical Center
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Saint Patrick Hospital - Community Hospital
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NC
Kenansville
ECU Health Oncology Kenansville
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Kinston
ECU Health Oncology Kinston
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Richlands
ECU Health Oncology Richlands
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NE
Kearney
CHI Health Good Samaritan
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Omaha
Alegent Health Bergan Mercy Medical Center
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NJ
Camden
Cooper Hospital University Medical Center
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Hackensack
Hackensack University Medical Center
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New Brunswick
Rutgers Cancer Institute of New Jersey
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Somerville
Robert Wood Johnson University Hospital Somerset
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Toms River
Community Medical Center
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Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
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NY
Bay Shore
Northwell Health Imbert Cancer Center
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Bronx
Montefiore Medical Center - Moses Campus
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Montefiore Medical Center-Einstein Campus
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Montefiore Medical Center-Weiler Hospital
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Lake Success
Northwell Health/Center for Advanced Medicine
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New York
Lenox Hill Hospital
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Manhattan Eye Ear and Throat Hospital
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Mount Sinai Chelsea
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Mount Sinai Hospital
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Mount Sinai Union Square
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Mount Sinai West
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Sleepy Hollow
Phelps Memorial Hospital Center
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Stony Brook
Stony Brook University Medical Center
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Valhalla
Westchester Medical Center
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OH
Cincinnati
Bethesda North Hospital
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Good Samaritan Hospital - Cincinnati
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University of Cincinnati Cancer Center-UC Medical Center
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Columbus
Ohio State University Comprehensive Cancer Center
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West Chester
University of Cincinnati Cancer Center-West Chester
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OK
Oklahoma City
Mercy Hospital Oklahoma City
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University of Oklahoma Health Sciences Center
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Email: ou-clinical-trials@ouhsc.edu
OR
Bend
Saint Charles Health System
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Email: nosall@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
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Email: CanRsrchStudies@providence.org
Providence Cancer Institute Clackamas Clinic
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Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
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Email: cherie.cox@bayareahospital.org
Gresham
Legacy Mount Hood Medical Center
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Newberg
Providence Newberg Medical Center
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Email: CanRsrchStudies@providence.org
Oregon City
Providence Willamette Falls Medical Center
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Email: CanRsrchStudies@providence.org
Portland
Legacy Good Samaritan Hospital and Medical Center
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Email: cancer@lhs.org
Oregon Health and Science University
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Email: trials@ohsu.edu
Providence Portland Medical Center
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Providence Saint Vincent Medical Center
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Tualatin
Legacy Meridian Park Hospital
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PA
Altoona
UPMC Altoona
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Email: ecog.rss@jimmy.harvard.edu
Beaver
UPMC-Heritage Valley Health System Beaver
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Email: haneydl@upmc.edu
Broomall
Crozer-Keystone Regional Cancer Center at Broomall
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Email: Jolene.garney@crozer.org
Carlisle
Carlisle Regional Cancer Center
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Drexel Hill
Delaware County Memorial Hospital
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East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
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Erie
UPMC Hillman Cancer Center Erie
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Farrell
UPMC Cancer Center at UPMC Horizon
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Furlong
Fox Chase Cancer Center Buckingham
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Glen Mills
Crozer Regional Cancer Center at Brinton Lake
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Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
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Harrisburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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Email: klitchfield@PINNACLEHEALTH.org
Hershey
Penn State Milton S Hershey Medical Center
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Email: CTO@hmc.psu.edu
Johnstown
UPMC-Johnstown/John P. Murtha Regional Cancer Center
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Mechanicsburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
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Monroeville
UPMC Cancer Center - Monroeville
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Email: ecog.rss@jimmy.harvard.edu
Moon Township
UPMC Hillman Cancer Center in Coraopolis
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Natrona Heights
UPMC Cancer Center-Natrona Heights
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New Castle
UPMC Hillman Cancer Center - New Castle
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Email: haneydl@upmc.edu
Philadelphia
Fox Chase Cancer Center
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Penn Presbyterian Medical Center
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Email: PennCancerTrials@careboxhealth.com
Temple University Hospital
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Thomas Jefferson University Hospital
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Email: ONCTrialNow@jefferson.edu
University of Pennsylvania/Abramson Cancer Center
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Email: PennCancerTrials@careboxhealth.com
Pittsburgh
UPMC-Magee Womens Hospital
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UPMC-Passavant Hospital
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UPMC-Saint Clair Hospital Cancer Center
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UPMC-Saint Margaret
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UPMC-Shadyside Hospital
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University of Pittsburgh Cancer Institute (UPCI)
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Seneca
UPMC Cancer Center at UPMC Northwest
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Uniontown
UPMC Cancer Center-Uniontown
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Email: ecog.rss@jimmy.harvard.edu
UPMC Uniontown Hospital Radiation Oncology
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Washington
UPMC Washington Hospital Radiation Oncology
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Email: cancer@washingtonhospital.org
Williamsport
UPMC Susquehanna
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York
UPMC Memorial
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SC
Charleston
Medical University of South Carolina
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Email: hcc-clinical-trials@musc.edu
SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
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Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
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Email: OncologyClinicalTrialsSF@SanfordHealth.org
TX
Dallas
UT Southwestern Simmons Cancer Center - RedBird
Contact: Site Public Contact
Email: canceranswerline@utsouthwestern.edu
UT Southwestern/Simmons Cancer Center-Dallas
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Email: canceranswerline@UTSouthwestern.edu
Fort Worth
UT Southwestern/Simmons Cancer Center-Fort Worth
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Email: canceranswerline@UTSouthwestern.edu
Richardson
UT Southwestern Clinical Center at Richardson/Plano
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Email: Suzanne.cole@utsouthwestern.edu
San Antonio
Audie L Murphy VA Hospital
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University of Texas Health Science Center at San Antonio
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Email: phoresearchoffice@uthscsa.edu
VA
Charlottesville
University of Virginia Cancer Center
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Email: uvacancertrials@hscmail.mcc.virginia.edu
Richmond
Virginia Commonwealth University/Massey Cancer Center
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Email: CTOclinops@vcu.edu
WA
Aberdeen
Providence Regional Cancer System-Aberdeen
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Email: deidre.dillon@providence.org
Bellingham
PeaceHealth Saint Joseph Medical Center
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Centralia
Providence Regional Cancer System-Centralia
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Email: deidre.dillon@providence.org
Edmonds
Swedish Cancer Institute-Edmonds
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Email: PCRC-NCORP@Swedish.org
Everett
Providence Regional Cancer Partnership
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Email: marilyn.birchman@providence.org
Issaquah
Swedish Cancer Institute-Issaquah
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Email: PCRC-NCORP@Swedish.org
Lacey
Providence Regional Cancer System-Lacey
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Email: deidre.dillon@providence.org
Longview
PeaceHealth Saint John Medical Center
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Email: kmakin-bond@peacehealth.org
Mount Vernon
Skagit Regional Health Cancer Care Center
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Email: rcccclinicalresearch@skagitvalleyhospital.org
Seattle
FHCC South Lake Union
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FHCC at Northwest Hospital
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Fred Hutchinson Cancer Center
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Swedish Medical Center-Ballard Campus
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Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
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Email: PCRC-NCORP@Swedish.org
University of Washington Medical Center - Montlake
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Sedro-Woolley
PeaceHealth United General Medical Center
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Email: lkey@peacehealth.org
Silverdale
Saint Michael Cancer Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
Vancouver
Legacy Cancer Institute Medical Oncology and Day Treatment
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Email: oncologyresearch@lhs.org
Legacy Salmon Creek Hospital
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PeaceHealth Southwest Medical Center
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Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
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Email: Cheryl.Dodd@providence.org
WI
Antigo
Langlade Hospital and Cancer Center
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Email: Juli.Alford@aspirus.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
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Email: oncology.clinical.trials@marshfieldresearch.org
Johnson Creek
University of Wisconsin Carbone Cancer Center - Johnson Creek
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Email: clinicaltrials@cancer.wisc.edu
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
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Email: clinicaltrials@cancer.wisc.edu
William S Middleton VA Medical Center
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Marshfield
Marshfield Medical Center-Marshfield
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Email: oncology.clinical.trials@marshfieldresearch.org
Minocqua
Marshfield Clinic-Minocqua Center
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Email: oncology.clinical.trials@marshfieldresearch.org
New Richmond
Cancer Center of Western Wisconsin
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Email: mmcorc@healthpartners.com
Rhinelander
Ascension Saint Mary's Hospital
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Email: Beth.Knetter@aspirus.org
Rice Lake
Marshfield Medical Center-Rice Lake
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Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Ascension Saint Michael's Hospital
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Email: Beth.Knetter@aspirus.org
Marshfield Medical Center-River Region at Stevens Point
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Email: oncology.clinical.trials@marshfieldresearch.org
Wausau
Aspirus Regional Cancer Center
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Weston
Marshfield Medical Center - Weston
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Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
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WY
Sheridan
Welch Cancer Center
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Email: mccinfo@mtcancer.org
PRIMARY OBJECTIVES: I. For patients without PET-evidence of extrapelvic metastases, to evaluate whether the addition of enhanced systemic therapy to standard of care (SOC) salvage radiation therapy (RT) could prolong progression-free survival (PFS). II. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could prolong PFS. SECONDARY OBJECTIVES: I. To evaluate overall survival in each arm. II. To evaluate event-free survival in each arm. III. To evaluate time to prostate-specific antigen (PSA) progression in each arm. IV. To assess the incidence of adverse events with the addition of enhanced systemic therapy in patients without PET-evidence of extrapelvic metastases. V. To assess the incidence of adverse events with local ablative metastasis-directed RT for PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases. VI. To estimate the detection rate of PET at the patient and regional level, and to evaluate its concordance with the follow-up Food and Drug Administration (FDA)-approved conventional imaging modalities (CIM) (as available) considered standard-of-care per institution, including computed tomography (CT), bone scintigraphy, magnetic resonance imaging (MRI) and PET imaging. VII. To determine the distribution of PET-positive lesions among anatomic sites (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) in patients with post-radical prostatectomy (RP) biochemical recurrence (BCR), correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters. EXPLORATORY OBJECTIVE: I. To determine the value of repeat PET (PET2) at time of second PSA progression, clinical concern for progression, or 12 months after completion of enhanced systemic therapy, whichever comes first to assess response to therapy (enhanced systemic therapy +/- focal RT and/or androgen deprivation therapy [ADT]) compared to available standard response assessments (PSA and CIM). QUALITY OF LIFE (QOL) PRIMARY OBJECTIVE: I. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy- Prostate (FACT-P) total score, at 6 months between the two sets of treatment arms (A with B and C with D). QOL SECONDARY OBJECTIVES: I. To compare the change in overall QOL, measured by FACT-P total score, from baseline to 6 months between the two sets of treatment arms (A with B and C with D). II. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scores) at 6 months between the two sets of treatment arms (A with B and C with D). III. To compare patient-reported overall QOL (FACT-P scores), fatigue (FACIT-Fatigue scores) and pain interference (Patient Reported Outcomes Measurement Information System [PROMIS] Pain Interference Short Form 4a) between the two sets of treatment arms (A with B and C with D) at the time of disease progression. QOL EXPLORATORY OBJECTIVES: I. To compare cognitive function, measured by FACT-Cognitive Function (Cog) PCI and total scores, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and ADT alone (Arm A) at 6 and 12 months. II. To compare the change in cognitive function, measured by change in FACT-Cog PCI and total scores, from baseline to 6 and baseline to 12 months, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and ADT alone (Arm A) at 6 and 12 months. III. To characterize longitudinal change in cognitive function between baseline and 24 months in patients with prostate cancer receiving treatment for BCR and define clinical and disease related characteristics associated with greater cognitive change by the FACT-Cog PCI and total scores. OUTLINE: STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. A subset of patients randomized to Arms C or D and receiving fluciclovine F18 intravenously (IV) or flotufolastat F-18 gallium IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using any other FDA-approved tracer for PET1 do not undergo PET2. STEP 1: Patients are randomized to 1 of 4 arms based on results of PET/CT or PET/MR in Step 0. ARM A (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC external beam radiation therapy (EBRT) for 6 months. Patients also receive goserelin acetate subcutaneously (SC), leuprolide acetate intramuscularly (IM), triptorelin IM, relugolix orally (PO), or degarelix SC for 6 months starting anytime between 7 days prior to Step 0 Registration and 14 days after Step 1 Randomization. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. ARM B (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO once daily (QD) for 6 months in the absence of disease progression or unacceptable toxicity. ARM C: (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B. ARM D (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo stereotactic body radiation therapy (SBRT) or 3-dimensional (3D) conformal radiation therapy (CRT), intensity-modulated radiation therapy (IMRT) (including volume modulated arc therapy [VMAT]), and intensity-modulated proton therapy (IMPT) over 3-10 fractions in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-5, and then annually for years 5-10.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.
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